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Aids in Formation of New Bone After Posterolateral Spinal Fusion Surgery

RAYNHAM, Mass. – January 6, 2014 - DePuy Synthes Spine, in collaboration with DePuy Synthes Biomaterials, announced today the U.S. launch of CONFORM SHEET™ *±, a hydrated, pliable and totally demineralized cancellous bone matrix that fills voids during posterolateral spinal fusion surgery and provides a natural scaffold for new bone formation.

The new allograft implant, processed by the Musculoskeletal Transplant Foundation (MTF), has both osteoinductive1,2 , and osteoconductive3 properties. Through a unique demineralization process, bone morphogenic proteins (BMPs) are exposed, providing CONFORM SHEET its osteoinductive properties, while the cancellous structure of the scaffold provides osteoconductive characteristics. CONFORM SHEET is wickable in that it readily absorbs various hydrating fluids including bone marrow aspirate, blood or saline. When combined with bone marrow aspirate, CONFORM SHEET becomes osteogenic4.

"CONFORM SHEET has excellent handling characteristics. It is compressible for precise placement, where it can then expand to fill the bone void,” said Khalid Sethi, MD, FACS, Chief of Neurosurgery at United Health Services Wilson Medical Center in Johnson City, NY. “It is packaged in a hydrated state, which eliminates the need for rehydration and there is no implant migration upon irrigation.”

CONFORM SHEET is offered in four sizes, which may be cut to accommodate irregular shaped anatomy. The implant may be used with DePuy Synthes Spine MATRIX™ MIS Pedicle Screw System and EXPEDIUM® Spine System, as well as other systems for spinal fusion.

“By adding CONFORM SHEET to our Spine portfolio, we continue to provide customers with robust procedural solutions to treat their spine patients,” said Max Reinhardt, Worldwide President, DePuy Synthes Spine. “We are pleased to collaborate across DePuy Synthes Companies with our Biomaterials colleagues to offer complete solutions that advance patient care. This is an excellent example of how, together, DePuy Synthes Companies can meet the needs of hospitals and health care systems.”

DePuy Synthes Spine also offers CONFORM CUBE®*≠ Demineralized Cancellous Bone, which launched in 2011. CONFORM CUBE is another fully demineralized cancellous bone product in the form of a cube. The implant comes in five sizes and has the same properties as the CONFORM SHEET, but does not come pre-hydrated.

“CONFORM SHEET and CONFORM CUBE exemplify our ongoing commitment to providing comprehensive and complementary biomaterials solutions to support the breadth of products the DePuy Synthes Companies offer,” said Elliott Gruskin, PhD, Worldwide President, DePuy Synthes Biomaterials. CONFORM SHEET and CONFORM CUBE are processed by MTF, resulting in tissue quality and safety through their approach to donor selection and allograft processing. DePuy Synthes Biomaterials has worked with MTF for more than 10 years to provide high-quality tissue for patients.

About DePuy Synthes Spine
DePuy Synthes Spine has one of the largest and most diverse portfolios of products and services in spinal care and is a global leader in traditional and minimally invasive spine treatment. The company offers procedural solutions for the full spectrum of spinal disorders including adult and adolescent deformity, spinal stenosis, trauma and degenerative disc disease. DePuy Synthes Spine is part of DePuy Synthes Companies of Johnson & Johnson, the largest provider of orthopaedic and neurological solutions in the world.

About DePuy Synthes Biomaterials
DePuy Synthes Biomaterials provides a wide range of innovative products that complement the use of traditional metal implants in trauma, spine and cranio-maxillofacial surgical procedures. Our biomaterials assist orthopaedic surgeons around the world with their mission to repair, protect and strengthen the structural core of the human body.

©DePuy Synthes Spine, a division of DOI 2013. All rights reserved.
©DePuy Synthes Biomaterials, a division of DOI 2013. All rights reserved.
*CONFORM SHEET and CONFORM CUBE are regulated as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product; pursuant to 21 CFR 1271.
±CONFORM SHEET is a trademark of the Musculoskeletal Transplant Foundation.
≠CONFORM CUBE is a registered trademark of the Musculoskeletal Transplant Foundation.

1 Data on file at MTF
2 M. Urist, “Bone Formation by Autoinduction.” Science, 1965; 150: 893-899.
3 Conform Cube: An Evaluation of a Fully Demineralized Cancellous Scaffold Seeded with Human Mesenchymal Cells (white paper); Musculoskeletal Transplant Foundation 2011. (00014CI)
4 R. McLain, J. Fleming, C. Boehm and G. Mushler. Aspiration of Osteoprogenitor Cells for Augmenting Spinal Fusion: Comparison of Progenitor Cell Concentration From The Vetebral Body and Iliac Crest. Journal of Bone and Joint Surgery. 2005: 2655-2661.